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Completed

NCT Number: NCT00215566

A Study to Evaluate the Safety, Tolerability and Pharmacodynamics of DDP733 for IBS-c

This study will evaluate the safety, tolerability and pharmacodynamics of the investigational drug DDP733 in treating subjects with IBS-c. A placebo control will be utilized.

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Key information

Conditions

Irritable Bowel Syndrome With Constipation Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Irritable Bowel Syndrome

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hys Medical Centre, Edmonton, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects must have a history of IBS-c for at least 3 months prior to randomization as assessed using ROME criteria
  • Must have had endoscopic/radiologic bowel evaluation within the past 10 years
  • Must comply with completing a daily diary and be able to comply with GI transit measurements, including swallowing capsules containing small x-ray visible markers
  • Female subjects cannot be pregnant, post-partum for less than 1 year or breastfeeding

Exclusion criteria

  • Serious underlying diseases, including psychiatric disorders
  • Current history of conditions affecting bowel transit
  • Recent history of biochemical or structural abnormalities of the gastrointestinal tract, gastrointestinal surgery, or gastrointestinal infection
  • Clinically significant abnormal examination findings or laboratory tests
  • Inability to stop taking certain medications, or a planned change in medications (including herbal remedies) which could interfere with study assessments
  • Use of drugs and or ethanol which may interfere with compliance of study procedures or influence study outcome
  • Presence of a medical condition which could interfere with the interpretation of study data
  • Significant use of nicotine or caffeine

Treatment and study plan

DDP733

Drug

Primary outcomes

  1. Evaluation of the effect of DDP733 on gastrointestinal transit

Secondary outcomes

  1. Evaluation of the effect of DDP733 on patient reported outcomes

Sponsors and collaborators

Lead sponsor

Dynogen Pharmaceuticals

Industry

Registry information

Official study title

A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of Multiple Doses and Dose Levels of DDP733 in Patients With Irritable Bowel Syndrome With Constipation

Important dates

Study start
2005
First posted
Sep 22, 2005
Registry last updated
May 28, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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